ACE COVID-19 IgG / IgM Dual Detection Kit

KIT COMPONENTS

Reagents and Consumables Included in the Kit

• Disposable Detection Card – 50 packages
• Sample Diluent Buffer (3 ml/vial) – 3 vials
• Instruction for Use – 1 copy

Material Required but not Provides

• External Positive controls and negative controls
• Serum blood collection tubes
• Plasma blood collection tubes
• Vortex mixer
• Sample storage tubes
• Desktop Centrifuge (for blood collection tubes and small storage tubes)
• Adjustable pipettes (10-100 µL)
• Sterile pipette tips with filters
• Powder free latex gloves
• Timer

STEPS

1. Equilibrate reagent card at room temperature. Open the inspection card aluminum foil bag. Remove the test card and place it horizontally on a table.
2. Use pipette to aspirate sample (serum, plasma or whole blood) and add 10 μl to the sample hole of the test card.
3. Add 60-70 μl sample dilution solution immediately.
4. Read the result at 15 min. Results after 20 minutes are invalid.

INTERPRETATION OF TEST RESULTS

1. Negative results: If only the quality control line C shows color and neither the G nor M test lines develop color, no 2019 novel coronavirus IgG/IgM antibody is detected, and the result is negative.
2. Positive results:
3. IgG/IgM dual detection card: If the two lines of quality control line C and detection line M develop color and the detection line G does not develop color, then the new coronavirus IgM antibody is detected, and the result is positive for the new coronavirus IgM antibody. If the two lines of the quality control line C and the detection line G develop color and the detection line M does not develop color, a new coronavirus IgG antibody is detected, and the result is positive for the new coronavirus IgG antibody. If the three lines of the quality control line C and the detection lines G and M are colored, the new coronavirus IgG and IgM antibodies are detected, and the results are positive for the new coronavirus IgG and IgM antibodies.
4. Invalid result: If the quality control line C does not develop color, regardless of whether the test line G/M develops color, the result is invalid, and the test needs to be performed again.
   
   

WARNING and PRECAUTIONS

1. For professional in vitro diagnostic use only.
2. Do not reuse.
3. Do not use if the product seal or its packaging is compromised.
4. Do not use the kits beyond their expiration date shown on the pouch.
5. Do not mix and interchange different specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection while handling potentially infectious materials or performing the assay.
7. Wash hands thoroughly after finishing the tests.
8. Do not eat, drink or smoke in the area where the specimens or kits are handled.
9. Clean up spillage thoroughly with appropriate disinfectants.
10. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing procedures.
11. Dispose of all specimens and used devices in a proper bio-hazard container. The handling and disposal of the hazardous materials should follow local, regional or national regulations.
12. Keep out of children's reach.

LIMITATIONS

1. This product is intended for research use only. 
2. Humidity and temperature can affect results adversely.
3. The test should not be performed when the environment is higher than 30℃ or the relative humidity is higher than 70%.
4. The instructions for the use of the test should be followed during testing procedures.
5. There is always a possibility that false results will occur due to the presence of interfering substances in the specimen or factors beyond the control of the manufacturer, such as technical or procedural errors associated with the testing.
6. This reagent has not yet evaluated the effects of vaccines, antiviral therapies, antibiotics, chemotherapy or immunosuppressants.
7. Although the test demonstrates superior accuracy in detecting antibodies against 2019-nCoV virus, a low incidence of false results can occur.
8. The positive result may be due to previous or current infection with other coronavirus strains other than 2019-nCoV virus. In order to confirm the positive results, additional examination and clinical evaluation should be carried out under the guidance of doctors.
9. The negative results DO NOT exclude the infection of 2019-nCoV virus. If the test results are negative, but the clinical symptoms persist, additional tests need to be performed using other analytical methods.
10. Improper storage or transportation conditions for serum, plasma or whole blood samples may lead to antibody degradation, resulting in false negative results.
11. The final clinical diagnosis should not be based only on the results of test of this product, but should only be issued by a doctor after evaluation of all clinical and laboratory findings.
12. The detection target of this reagent is SARS-CoV-2 IgM/IgG antibody. A positive result cannot directly reflect the presence of the SARS-CoV-2 virus in the subject.
13. It is not yet known whether the presence of SARS-CoV-2 antibodies in the body can prevent or reduce secondary infections.
14. For subjects with impaired immune function or undergoing immuno-suppressive therapy, the test results of this reagent have limited reference value.
15. This reagent should not be used to screen donated blood samples.

PERFORMANCE CHARACTERISTICS

1. Cross-Reactivity/Analytical Specificity

Cross-reactivity of the Anti-SARS-CoV-2 Rapid Test was evaluated using serum samples containing antibodies against high-risk groups. 118 potential cross-reactant serum samples were tested, no IgM or IgG false positive results were observed with the following potential cross-reactants:

Table 1. Cross-reactivity results

Note 1: Medical staff: doctors, nurses, ward cleaners

Note 2: Suspected symptoms (not PCR tested) (fever, cough, sore throat, runny nose)

2. Clinical Studies

Retrospective serum/plasma samples were collected from 27 COVID-19 positive patients confirmed by an FDA authorized SARS-CoV-2 PCR test. Negative retrospective serum/plasma samples were collected from 51 COVID-19 PCR negative samples. Testing of serum samples using ACE COVID-19 IgG / IgM Dual Detection Kit was conducted at the Reach Reference Laboratory in New Taipei City, Taiwan.

Table 2. Overall clinical study results for all time periods from symptom onset

*Note: Serum and plasma samples were collected from the same patients for serology testing between 1 day and > 30 days after PCR sample collection.

Positive Percent Agreement (PPA)= (IgM positive or IgG positive)/(PCR positive)

PPA: 96.80% (26/27)

Negative Percent Agreement: (NPA) = (IgM negative and IgG negative)/(PCR negative)

NPA: 100.00% (51/51)